HIV/AIDS, SEVERE MENTAL ILLNESS AND HOMELESSNESS
RELEASE DATE: November 18, 2003
PA NUMBER: PA-04-024
November 27, 2006 - The R01 portion of this funding opportunity has been replaced by PA-07-090,
which now uses the electronic SF424 (R&R) application for February 5, 2007 submission dates and beyond.
March 2, 2006 (NOT-OD-06-046) – Effective with the June 1, 2006 submission date,
all R03, R21, R33 and R34 applications must be submitted through Grants.gov using
the electronic SF424 (R&R) application. This announcement will stay active for
only the May 1, 2006 AIDS and AIDS-related application submission date for these
mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms
expires on the date indicated below. Other mechanisms relating to this announcement
will continue to be accepted using paper PHS 398 applications until the stated
expiration date below, or transition to electronic application submission. Parent
R03 (PA-06-180) and R21 (PA-06-181) funding opportunity announcements have been
issued for the submission date of June 1, 2006 and submission dates for AIDS and
non-AIDS applications thereafter. Applications relating to R33 and R34 activities
must be in response to NIH Institute/Center (IC)-specific announcements.
EXPIRATION DATE for R03 and R21 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for R03 and R21 AIDS and AIDS-Related Applications: May 2, 2006
EXPIRATION DATE for R01 Non-AIDS Applications: November 2, 2006
EXPIRATION DATE for R01 AIDS and AIDS-Related Applications: January 3, 2007
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENTS OF PARTICIPATING ORGANIZATION:
National Institute of Mental Health (NIMH)
(http://www.nimh.nih.gov/)
National Institute on Drug Abuse (NIDA)
(http://www.nida.nih.gov)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
(http://www.niaaa.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.242, 93.279, 93.273
THIS PA CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS PA
This PA replaces PA-98-080.
The overall focus of this Program Announcement (PA), sponsored by the NIMH,
NIAAA and NIDA, is to refocus research on persons with severe mental illness
(SMI), either before or after HIV infection, and to expand HIV-related research
to homeless persons. This PA solicits studies on the SMI population and/or
homeless persons with special attention to the development, implementation, and
evaluation of effective HIV-prevention interventions and their dissemination and
translation to the community and public health service organizations. We also
solicit studies on the SMI population and/or homeless persons that propose
improved methodologies to study descriptive/analytic epidemiology of HIV
infection and epidemiology of the behavior associated with risk and the spread
of HIV infection. An important objective of this PA is to encourage integration
both across and within the different research areas by establishing
multidisciplinary research teams and collaborative alliances.
RESEARCH OBJECTIVES
Over the past decade there have been significant advances in research on the
U.S. epidemic of HIV infection among people with the most severe and persistent
mental illnesses. To date, research has concentrated largely on the following
areas: (1) cross sectional studies of regional HIV seroprevalence in SMI in
predominantly urban sections of the country, (2) studies of risk, transmission,
and behavioral epidemiology, and (3) research on cognitive behavior and skill-
based risk reduction interventions in adult SMI. However, research is still
needed in a number of crucial areas on HIV/AIDS and the SMI, and the links with
homeless persons have become more obvious, demanding immediate research
attention (discussed below). Epidemiological estimates indicate that about
one-third of all homeless, single adults have severe and persistent mental
illness and have marked neuropsychological impairments in attention, executive
functioning, verbal memory, and general intellectual functioning. Substance use
and abuse estimates are extremely high for homeless adolescents and adults,
including alcohol and injection drug use (ranging from 20-80%). Available data
suggest that in major urban areas, 10-20% of homeless persons who suffer from
chronic mental illnesses are infected with HIV. Nationwide, homeless adults are
a population at high risk for HIV, due to disproportionate rates of injection
drug use, unprotected sexual activity, prostitution, and victimization.
Moreover, those who are often marginalized, such as the homeless, suffer from
other co-infections (e.g., tuberculosis, hepatitis C virus), multiple
comorbidities (e.g., substance abuse, mental illness), and a wide range of
chronic health conditions (e.g., arthritis, heart disease, high blood pressure,
emphysema/bronchitis, cirrhosis, kidney disorder, seizure disorder). The
multiple conditions affecting HIV disease in homeless persons may accelerate HIV
disease course, add significant complications to the manifestations of HIV
disease and its CNS sequelae, and challenge the available prevention strategies
and service delivery systems.
Research is needed to better understand the prevalence of HIV and AIDS among
persons with SMI, with drug abusing behaviors, and/or who are homeless across
the U.S. Epidemiological research must look broadly at HIV-related risk
behavior and examine the extent and social organization of sexual and drug-use
behavior. Research efforts might begin by targeting high-risk individuals in
community samples and then extend into the general population of individuals
troubled by the most severe mental illnesses. Epidemiological research needs to
be broadened to samples of patients with preexisting mental illness, mental
illness secondary to HIV infection, and to others suffering from mental illness
within the community. Research is needed to address: improved methodological
procedures; longitudinal studies in multiple U.S. regions including incidence
data; validating self-reported data; increased generalizability to the general
population; the role of contextual factors; linking risk taking to specific
aspects of SMI; and longitudinal studies on patterns of risk taking over time;
and connecting between the content of HIV preventive interventions to
potentially risky situations actually encountered by SMI individuals. HIV
research in homeless persons must address: the relative role of co-infections
and comorbidities; a range of settings including forensic, shelters, new
admissions and long-stay; developmental trajectories to and out of homelessness
in youth; risk research in children of homeless adults; and adherence research
in homeless persons with multiple comorbidities.
In spite of some positive behavior change outcomes of HIV preventive interventions
for this population, research on risk reduction approaches for mentally ill persons
is still in its very early stages. We must develop a “combination” approach to HIV
prevention in the SMI and homeless that incorporates a range of biomedical,
behavioral, and social interventions that work on all levels of social organization
from individuals to whole societies. We need a broader repertoire of intervention
models and these models must be assessed at multiple levels including individual,
system, network, care provider and community. HIV prevention programs will have to
be integrated into outreach, transitional living, and community services for the
SMI by translating effective HIV prevention methods for the SMI to applied mental
health and public health care systems. Strategies should be developed for
sustained long-term effectiveness of HIV preventive programs across multiple care
and social service systems for the SMI and/or homeless through integration,
coordination and linkages with psychiatric, alcohol, drug abuse, and medical
therapies. Better implementation of effective interventions will require a
dialogue among researchers, public health practitioners, policymakers, and
community constituencies as well as an improved science of research dissemination.
Implementation must be followed by assessment of the extent to which people with
SMI do in fact actually receive HIV-related medical care. Interventions will
succeed only if they are linked to efforts to address the macrosocial conditions
that contribute to HIV vulnerability and other infectious diseases and their
consequences. This is especially important for the SMI and the homeless because of
the layers of stigma from infection, psychiatric illness, alcohol/drug abuse, life
style, and inequalities based on race/ ethnicity, discrimination, economic class,
or sexual identity.
Areas of Research Interest
The following are examples of broad research topics that might be the focus of
research on HIV/AIDS in persons with SMI and/or homelessness (mentally ill
populations other than the SMI may sometimes be relevant). The list of examples is
not meant to be comprehensive nor exclusive of other topics.
Epidemiology, Risk, and Protective Factors
o Epidemiological multisite research of population-based samples on at-risk and
HIV infected individuals with a psychiatric diagnosis and alcohol/drug abuse
disorders, including all races and ethnic groups, children, adolescents, and adults
living in multiple urban, suburban, and rural regions of the U.S.
o Due to the multiple stigmas around mental illness, homelessness, alcohol and
substance abuse disorders, and HIV/AIDS, research is needed to examine ways in
which stigma and discrimination or other social, economic cultural and
environmental conditions contribute to, or create sources of, HIV-related risk and
develop interventions based on this understanding.
o Because traditionally underserved populations with mental illness, homelessness,
alcohol and drug abuse, and HIV/AIDS are skeptical about treatment and care, novel
recruitment, engagement and retention strategies are needed to reach and retain
persons least likely to seek help and to conduct research on effectiveness of
alternative access methods that may involve either faith-based or other community
organizations.
o Increased attention to individually perceived protective factors (e.g., reason
for living) in the context of known risk factors, trait or state dimensions (such
as impulsivity or impaired executive functioning), that increase risk of HIV
infection and the role of cultural factors and acculturative processes that can
modify risk and its perception as well as influencing protective factors (e.g.,
religiosity).
o Longitudinal research of HIV-related risk taking at individual and community
levels in the SMI and homeless.
Comorbidities and Complications
o Studies of medical or neuropsychiatric manifestations of HIV infection that may
result in onset of SMI or may co-occur with homelessness (e.g., neurocognitive
disorders related to HIV with or without Hepatitis-C co-infection, psychotic
disorders, delirium, CNS opportunistic infections and tumor, systemic
abnormalities, psychoactive agents, adverse effects of certain medical treatments,
Hepatitis C Virus).
o Research to evaluate the effect of co-infection (especially with HBV, HCV or TB)
on the management of HIV in SMI or homeless persons and to determine the bi-
directional effects of co-infection and treatments on disease progression and drug
interactions.
o Evaluation of potential therapies for the prevention and treatment of HIV-
associated infections and co-infections and research on treatment of comorbidities;
prevention of early comorbid patterns in reducing risk, increasing the efficacy of
HIV risk-reduction and adherence interventions in the SMI or homeless persons.
o Studies to determine the impact co-infection with HBV, HCV, or TB on immune
dysfunction, HIV progression and HIV-therapy associated reconstitution in SMI.
o Research to discover mechanisms underlying the relationships among co-occurring
disorders and HIV and potentially modifiable biological substrates that link co-
infections and comorbidites to HIV disease in the SMI and homeless persons.
Multilevel Prevention and Treatment Services
o Studies of structural, community, social network and societal/cultural level
interventions to reduce high risk behaviors and prevent HIV infection in the SMI
and homeless and go beyond the standard individual-level randomized trial
interventions.
o Studies to adapt effective HIV preventive interventions to the SMI, homeless,
and other underserved marginalized populations.
o Research to address the multiple comorbidities and complications in HIV-infected
individuals with SMI and/or homelessness through the development of integrated
treatment and care of mental illness and substance abuse and improved linkages with
the specialty medical care system.
o Increased attention to under-developed prevention modalities and sub-
populations of the SMI and homeless, such as the development of newer methods of
prevention (e.g., microbicides, vaccines) and HIV prevention among infected
individuals.
o Research on mental health and substance abuse service needs or service system
organization and assessment of the most effective methods for providing and
financing services to HIV-infected individuals with SMI and homelessness.
Technology Transfer and Information Dissemination
o Studies that translate research results into community programs for HIV-infected
persons with SMI and homelessness, moving from research interventions to ongoing
public health programs and cost effectiveness.
o Development of outcome measures and suitable methodologies for dissemination and
dissemination/implementation approaches that accurately assess the success of an
approach to move evidence into practice.
o Studies on the fidelity of implementation efforts, including the identification
of components of implementation that will enable fidelity to be assessed
meaningfully.
o Studies on the dissemination of effective HIV-intervention strategies that also
test the utility of alternative dissemination strategies for service delivery
systems targeting the SMI, homeless, and/or other related underserved populations.
o Research to identify factors (system, organizational, individual) necessary to
enhance an alliance of trust between the provider and client, facilitate treatment
readiness and maximize consumer participation and engagement in HIV prevention,
outreach, transitional living and community services for the homeless and/or
persons with SMI
MECHANISMS OF SUPPORT
This PA will use the NIH Research Project Grant (R01), collaborative R01s, Small
Grant (R03), Exploratory/Developmental Grant (R21) award mechanism(s). As an
applicant, you will be solely responsible for planning, directing, and executing
the proposed project.
Information on the Collaborative R01 mechanism is available at:
http://grants.nih.gov/grants/guide/pa-files/PA-01-123.html
Information on the Small Grant (R03) is available at:
http://grants.nih.gov/grants/guide/pa-files/PA-03-108.html
Information on the Exploratory/Developmental Grant (R21) is available at:
http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html
This PA uses just-in-time concepts. It also uses the modular budgeting format.
(see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if
you are submitting an application with direct costs in each year of $250,000 or
less, use the modular format. This program does not require cost sharing as
defined in the current NIH Grants Policy Statement at
http://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm.
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) if your institution has any of the following
characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals, and
laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic or foreign institutions/organizations
o Faith-based or community-based organizations
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry out the
proposed research is invited to work with their institution to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply for
NIH programs.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this PA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into two areas:
scientific/research and financial or grants management issues:
o Direct your questions about scientific/research issues to:
David M. Stoff, Ph.D.
Division of Mental Disorders Behavioral Research and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6210, MSC 9619
Bethesda, MD 20892-9619
Telephone: (301) 443-4625
FAX: (301) 443-9719
Email: dstoff@nih.gov
Mike Hilton, Ph.D.
Office of Collaborative Research
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 302
Bethesda, MD 20892-7003
Telephone: (301) 402-9402
Fax: (301) 480-2358
Email: mhilton@niaa.nih.gov
Jerry Flanzer, Ph.D.
Division of Epidemiology, Services and Prevention Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4222, MSC 9565
Bethesda, MD 20892-9565
Telephone: (301) 443-4060
FAX: (301) 443-6815
Email: Jflanzer@nida.nih.gov
Helen Cesari, MSc.
Center of Center on AIDS and Other Medical Consequences of Drug Abuse
National Institute on Drug Abuse
6001 Executive Boulevard, Room 5173
Bethesda, MD 20892
Telephone: (301) 443-1801
FAX: (301) 480-4544
Email: Hcesari@nida.nih.gov
o Direct your questions about financial or grants management matters to:
Brian Albertini
Division of Mental Disorders, Behavioral Research, and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6135, MSC 9605
Bethesda, MD 20852-9605
Telephone: (301) 443-0004
FAX: (301) 443-6885
Email: albertib2@mail.nih.gov
Judy Fox (formerly Simons)
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 504
Bethesda, MD 20892-7003
Telephone: (301) 443-4704
FAX: (301) 443-3891
Email: jsimons@willco.niaaa.nih.gov
Diana Haikalis, MBA
Office of Extramural Affairs
National Institute on Drug Abuse
6101 Executive Boulevard, Suite 242, MSC 8403
Bethesda, MD 20892-8403 (express/courier service)
Telephone: (301) 443-6710
FAX: (301) 443-7595
Email: dhaikali@nida.nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet
(D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier
when applying for Federal grants or cooperative agreements. The DUNS number can be
obtained by calling (866) 705-5711 or through the web site at
http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of
the face page of the PHS 398 form. The PHS 398 is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format.
For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email:
GrantsInfo@nih.gov.
The title and number of the PA must be typed in line 2 of the face page of the
application form and the YES box must be checked.
APPLICATION RECEIPT DATES: Applications submitted in response to this program
announcement will be accepted at the standard application deadlines, which are
available at http://grants.nih.gov/grants/dates.htm. Application deadlines are
also indicated in the PHS 398 application kit.
SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS: Applications
requesting up to $250,000 per year in direct costs must be submitted in a modular
budget grant format. The modular budget grant format simplifies the preparation of
the budget in these applications by limiting the level of budgetary detail.
Applicants request direct costs in $25,000 modules. Section C of the research
grant application instructions for the PHS 398 (rev. 5/2001) at
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step
guidance for preparing modular grants. Additional information on modular grants is
available at http://grants.nih.gov/grants/funding/modular/modular.htm.
SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR:
Applications requesting $500,000 or more in direct costs for any year must include
a cover letter identifying the NIH staff member within one of NIH institutes or
centers who has agreed to accept assignment of the application.
Applicants requesting more than $500,000 must carry out the following steps:
1) Contact the IC program staff at least 6 weeks before submitting the application,
i.e., as you are developing plans for the study;
2) Obtain agreement from the IC staff that the IC will accept your application for
consideration for award; and,
3) Identify, in a cover letter sent with the application, the staff member and IC
who agreed to accept assignment of the application.
This policy applies to all investigator-initiated new (type 1), competing
continuation (type 2), competing supplement, or any amended or revised version of
these grant application types. Additional information on this policy is available
in the NIH Guide for Grants and Contracts, October 19, 2001 at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the
application, including the checklist, and five signed photocopies in one package
to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates
described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR
will not accept any application in response to this PA that is essentially the same
as one currently pending initial review unless the applicant withdraws the pending
application. The CSR will not accept any application that is essentially the same
as one already reviewed. This does not preclude the submission of a substantial
revision of an unfunded version of an application already reviewed, but such
application must include an Introduction addressing the previous critique.
Although there is no immediate acknowledgement of the receipt of an application,
applicants are generally notified of the review and funding assignment within 8
weeks.
PEER REVIEW PROCESS
Applications submitted for this PA will be assigned on the basis of established PHS
referral guidelines. Appropriate scientific review groups convened in accordance
with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm)
will evaluate applications for scientific and technical merit.
As part of the initial merit review, all applications will:
o Undergo a selection process in which only those applications deemed to have the
highest scientific merit, generally the top half of applications under review, will
be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the appropriate national advisory council or
board
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of biological
systems, improve the control of disease, and enhance health. In the written
comments, reviewers will be asked to discuss your application in order to judge the
likelihood that the proposed research will have a substantial impact on the pursuit
of these goals. The scientific review group will address and consider each of
these criteria in assigning the application’s overall score, weighting them as
appropriate for each application.
o Significance
o Approach
o Innovation
o Investigator
o Environment
The application does not need to be strong in all categories to be judged likely to
have major scientific impact and thus deserve a high priority score. For example,
an investigator may propose to carry out important work that by its nature is not
innovative but is essential to move a field forward.
SIGNIFICANCE: Does this study address an important problem? If the aims of the
application are achieved, how will scientific knowledge be advanced? What will be
the effect of these studies on the concepts or methods that drive this field?
APPROACH: Are the conceptual framework, design, methods, and analyses adequately
developed, well-integrated, and appropriate to the aims of the project? Does the
applicant acknowledge potential problem areas and consider alternative tactics?
INNOVATION: Does the project employ novel concepts, approaches or methods? Are
the aims original and innovative? Does the project challenge existing paradigms or
develop new methodologies or technologies?
INVESTIGATOR: Is the investigator appropriately trained and well suited to carry
out this work? Is the work proposed appropriate to the experience level of the
principal investigator and other researchers (if any)?
ENVIRONMENT: Does the scientific environment in which the work will be done
contribute to the probability of success? Do the proposed experiments take
advantage of unique features of the scientific environment or employ useful
collaborative arrangements? Is there evidence of institutional support?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items
will be considered in the determination of scientific merit and the priority score:
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects
and protections from research risk relating to their participation in the proposed
research will be assessed. (See criteria included in the section on Federal
Citations, below).
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to
include subjects from both genders, all racial and ethnic groups (and subgroups),
and children as appropriate for the scientific goals of the research will be
assessed. Plans for the recruitment and retention of subjects will also be
evaluated. (See Inclusion Criteria in the sections on Federal Citations, below).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be
used in the project, the five items described under Section f of the PHS 398
research grant application instructions (rev. 5/2001) will be assessed.
ADDITIONAL REVIEW CONSIDERATIONS
SHARING RESEARCH DATA: Applicants requesting more than $500,000 in direct costs in
any year of the proposed research are expected to include a data sharing plan in
their application. The reasonableness of the data sharing plan or the rationale
for not sharing research data will be assessed by the reviewers. However,
reviewers will not factor the proposed data sharing plan into the determination of
scientific merit or priority score.
BUDGET: The reasonableness of the proposed budget and the requested period of
support in relation to the proposed research.
AWARD CRITERIA
Applications submitted in response to a PA will compete for available funds with
all other recommended applications. The following will be considered in making
funding decisions:
o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities
REQUIRED FEDERAL CITATIONS
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications
and proposals involving human subjects must be evaluated with reference to the
risks to the subjects, the adequacy of protection against these risks, the
potential benefits of the research to the subjects and others, and the importance
of the knowledge gained or to be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all
types of clinical trials, including physiologic, toxicity, and dose-finding studies
(phase I); efficacy studies (phase II), efficacy, effectiveness and comparative
trials (phase III). The establishment of data and safety monitoring boards (DSMBs)
is required for multi-site clinical trials involving interventions that entail
potential risk to the participants. (NIH Policy for Data and Safety Monitoring,
NIH Guide for Grants and Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date,
investigators submitting an NIH application seeking more than $500,000 or more in
direct costs in any single year are expected to include a plan for data sharing or
state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their institutions, on issues related to
institutional policies, local IRB rules, as well as local, state and Federal laws
and regulations, including the Privacy Rule. Reviewers will consider the data
sharing plan but will not factor the plan into the determination of the scientific
merit or the priority score.
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the
NIH that women and members of minority groups and their sub-populations must be
included in all NIH-supported clinical research projects unless a clear and
compelling justification is provided indicating that inclusion is inappropriate
with respect to the health of the subjects or the purpose of the research. This
policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43).
All investigators proposing clinical research should read the "NIH Guidelines for
Inclusion of Women and Minorities as Subjects in Clinical Research - Amended,
October, 2001," published in the NIH Guide for Grants and Contracts on October 9,
2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical research;
updated racial and ethnic categories in compliance with the new OMB standards;
clarification of language governing NIH-defined Phase III clinical trials
consistent with the new PHS Form 398; and updated roles and responsibilities of NIH
staff and the extramural community. The policy continues to require for all NIH-
defined Phase III clinical trials that: a) all applications or proposals and/or
protocols must provide a description of plans to conduct analyses, as appropriate,
to address differences by sex/gender and/or racial/ethnic groups, including
subgroups if applicable; and b) investigators must report annual accrual and
progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic
group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The
NIH maintains a policy that children (i.e., individuals under the age of 21) must
be included in all human subjects research, conducted or supported by the NIH,
unless there are scientific and ethical reasons not to include them. This policy
applies to all initial (Type 1) applications submitted for receipt dates after
October 1, 1998.
All investigators proposing research involving human subjects should read the "NIH
Policy and Guidelines" on the inclusion of children as participants in research
involving human subjects that is available at
http://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy
requires education on the protection of human subject participants for all
investigators submitting NIH proposals for research involving human subjects. You
will find this policy announcement in the NIH Guide for Grants and Contracts
Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on
hESCs can be found at http://stemcells.nih.gov/index.asp and at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research
using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry
will be eligible for Federal funding (see http://escr.nih.gov). It is the
responsibility of the applicant to provide, in the project description and
elsewhere in the application as appropriate, the official NIH identifier(s)for the
hESC line(s)to be used in the proposed research. Applications that do not provide
this information will be returned without review.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office
of Management and Budget (OMB) Circular A-110 has been revised to provide public
access to research data through the Freedom of Information Act (FOIA) under some
circumstances. Data that are (1) first produced in a project that is supported in
whole or in part with Federal funds and (2) cited publicly and officially by a
Federal agency in support of an action that has the force and effect of law (i.e.,
a regulation) may be accessed through FOIA. It is important for applicants to
understand the basic scope of this amendment. NIH has provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this PA in a public archive,
which can provide protections for the data and manage the distribution for an
indefinite period of time. If so, the application should include a description of
the archiving plan in the study design and include information about this in the
budget justification section of the application. In addition, applicants should
think about how to structure informed consent statements and other human subjects
procedures given the potential for wider use of data collected under this award.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The
Department of Health and Human Services (DHHS) issued final modification to the
“Standards for Privacy of Individually Identifiable Health Information”, the
“Privacy Rule,” on August 14, 2002. The Privacy Rule is a federal regulation under
the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that
governs the protection of individually identifiable health information, and is
administered and enforced by the DHHS Office for Civil Rights (OCR). Those who
must comply with the Privacy Rule (classified under the Rule as “covered entities”)
must do so by April 14, 2003 (with the exception of small health plans which have
an extra year to comply).
Decisions about applicability and implementation of the Privacy Rule reside with
the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text and
a set of decision tools on “Am I a covered entity?” Information on the impact of
the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress
monitoring of grants, cooperative agreements, and research contracts can be found
at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for
NIH funding must be self-contained within specified page limitations. Unless
otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be
used to provide information necessary to the review because reviewers are under no
obligation to view the Internet sites. Furthermore, we caution reviewers that
their anonymity may be compromised when they directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the
health promotion and disease prevention objectives of "Healthy People 2010," a PHS-
led national activity for setting priority areas. This PA is related to one or
more of the priority areas. Potential applicants may obtain a copy of "Healthy
People 2010" at http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal
Domestic Assistance at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health Systems
Agency review. Awards are made under the authorization of Sections 301 and 405 of
the Public Health Service Act as amended (42 USC 241 and 284) and under Federal
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the
terms and conditions, cost principles, and other considerations described in the
NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at
http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-free workplace
and discourage the use of all tobacco products. In addition, Public Law 103-227,
the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some
cases, any portion of a facility) in which regular or routine education, library,
day care, health care, or early childhood development services are provided to
children. This is consistent with the PHS mission to protect and advance the
physical and mental health of the American people.